Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for walking with full or partial weight support.
II. Promote weight bearing, balance, and reciprocal leg movement in these patients.
III. Elicit synchronized motor output within and between limbs in these patients.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||July 1995|
PROTOCOL OUTLINE: This is a controlled, prospective study. Patients pairs matched for strata are randomly assigned to 1 of 2 treatment groups. Patients are stratified into pairs by age, time since onset, Frankel grade, and Motor Score Index.
One group receives body weight-supported treadmill training immediately after baseline clinical, biomechanical, and physiological measures. The second group is the control; baseline measures are identical but training is delayed for 3 months.
Patients in both groups receive training 3 days/week for 3 months. Initial treadmill velocity is 18 meters/minute; velocity is increased in increments of 6 meters/minute until the maximum speed is achieved at which each patient exhibits the best locomotor capability at full weight bearing. Patients are trained with the minimal weight support assistance necessary for effective limb progression without excessive knee flexion or hyperextension. Polypropylene ankle-foot orthosis is allowed.
Patients are re-tested after maximal treadmill velocity is achieved: following clonidine once a day for 3 days; clonidine twice a day for 3 days; cyproheptadine for 3 days; and an increased dose of cyproheptadine for 3 days. There is a 3-day washout between clonidine and cyproheptadine testing.
Patients are not advanced if they experience adverse cardiovascular effects during therapy. No concurrent therapeutic exercise for the lower extremities is allowed.
Kinematic, temporal, kinetic, spasticity, Frankel grading, Motor Index Score, metabolic, and functional outcome measures are evaluated at 3 and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004812
|Study Chair:||Bruce Dobkin||University of California, Los Angeles|